FDA commissioner Scott Gottlieb wants to encourage compounding pharmacies to register under a law that brings such businesses under the authority of the FDA rather than state pharmacy boards, according to new reports from Reuters.
Pharmacies that specialize in compounding services make custom medications by combining, or compounding, FDA-approved drugs in strengths personalized to an individual patient.
After a meningitis outbreak linked to a now-defunct compounder, the New England Compounding Center, turned deadly in 2012, Congress passed the Drug Quality and Security Act. The law established that compounding pharmacies could register with the FDA and be allowed to sell products to hospitals and physician practices without prescriptions for individual patients.
In registering with the FDA, the pharmacies are required to follow federal manufacturing standards and be available for routine inspections.
Around 70 companies have registered under such a category, called “outsourcing facilities”, according to Reuters.
If a compounder decided not to register with the FDA, it remains under state authority and is restricted to selling compound drugs for specific patients with a prescription.
In an effort to encourage more compounding pharmacies to register, the FDA is slated to release draft guidance in the next two months, Gottlieb said. The guidance will establish the regulatory agency’s intention to recalibrate its enforcement priorities based on the size of the compounder and the risk associated with its product.
“We’re looking at ways we can provide more of a gradation in our regulatory architecture so we don’t have a one-size-fits-all approach,” Gottlieb told the newswire.
Groups like the American Pharmacists Association have criticized the FDA in the past, arguing that the federal group was overstepping its bounds by regulating state-licensed pharmacies.
Gottlieb said he stands by the FDA and that he expects no slowdown in terms of its enforcement of the 2013 law. New guidance, he said, will address the concerns voiced by smaller pharmacies that are worried about the expense of regulatory compliance.
The upcoming draft guidance will establish less burdensome regulatory requirements for smaller firms compared with larger outsourcing facilities.
“I want to move more of them into a compliant space, and I‘m willing to work with compounders and the broader community to find some regulatory accommodation that gets more of them into a compliant space,” he told Reuters.